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Abstract:

Scientifically Modulated And Reprogrammed Treatment (SMART) Virus Fas/FasL
technology is intended to terminate T-Helper cells infected with the
Human Immunodeficiency Virus. The SMART-Fas/FasL Virus carrying Fas and
FasL cell-surface receptors is capable of engaging a T-Helper cell
infected by HIV that is expressing one or more FasL cell-surface
receptors. When a T-Helper cell infected with HIV encounters a
SMART-Fas/FasL Virus, the infected T-Helper cell's FasL cell-surface
receptor will engage the SMART-Fas/FasL Virus's Fas receptor, then the
SMART-Fas/FasL Virus's FasL will engage the infected T-Helper cell's Fas
receptor, which will initiate apoptosis in the infected T-Helper cell.
Given the HIV infected T-Helper cell will be triggered to die, HIV's safe
haven inside the T-Helper cell will be eliminated and the threat of
Acquired Immunodeficiency Syndrome caused by HIV is averted.

Claims:

1. A medical device comprised of a lipid bilayer envelope, represented as
an independent sheet or a covering, which affixed to the said envelope
are two or more different types of cell-surface receptors intended to
attract and functionally engage a target leukocyte with the intention of
terminating the target leukocyte for medical treatment purposes.

2. A medical device comprised of a lipid bilayer envelope, represented as
an independent sheet or a covering, which affixed to the said envelope
are one or more Fas cell-surface receptors and one or more FasL
cell-surface receptors for medical treatment purposes.

3. A medical device comprised of a lipid bilayer envelope, represented as
an independent sheet or a covering, which affixed to the said envelope
are two or more different types of cell-surface receptors intended to
attract and functionally engage an infected eukaryote with the intention
of terminating the infected eukaryote for medical treatment purposes.

4. A medical device comprised of a lipid bilayer envelope, represented as
an independent sheet or a covering, which affixed to the said envelope
are two or more different types of cell-surface receptors intended to
attract and functionally engage target cell-surface receptors located on
the surface of a T-Helper cell infected with Human Immunodeficiency Virus
with the intention of terminating the infected T-Helper cell for the
purpose of neutralizing the infectious threat of the Human
Immunodeficiency Virus.

5. A medical device comprised of a lipid bilayer envelope, represented as
an independent sheet or a covering, which affixed to the said envelope
are one or more Fas cell-surface receptors and one or more FasL
cell-surface receptors intended to attract and functionally engage target
cell-surface receptors located on the surface of one or more T-Helper
cells infected with Human Immunodeficiency Virus, where the Fas
cell-surface receptor is present on the envelope of the medical device in
a fashion that the Fas cell-surface receptor will be physically engaged
by an infected T-Helper cell before an FasL receptor can be physically
engaged by the same infected T-Helper cell, with the intention of
initiating apoptosis in T-Helper cells infected with the Human
Immunodeficiency Virus in order to terminate these same T-Helper cells
infected with the Human Immunodeficiency Virus for the purpose of
neutralizing the infectious threat of the Human Immunodeficiency Virus.

6. A medical device comprised of a capsid shell constructed of repeating
capsid proteins, this capsid shell encapsulated by matrix proteins,
further encapsulated by an exterior lipid bilayer envelope, which affixed
to the outer envelope are two or more different types of exterior
cell-surface receptors intended to attract and functionally engage target
cell-surface receptors located on the surface of a T-Helper cell infected
with Human Immunodeficiency Virus with the intention of initiating
apoptosis in T-Helper cells infected with the Human Immunodeficiency
Virus in order to terminate these same T-Helper cells infected with the
Human Immunodeficiency Virus for the purpose of neutralizing the
infectious threat of the Human Immunodeficiency Virus.

7. A medical device comprised of a capsid shell constructed of repeating
capsid proteins, this capsid shell encapsulated by matrix proteins,
further encapsulated by an exterior lipid bilayer envelope, which affixed
to the outer envelope are one or more exterior surface cell-receptors
known as Fas, as found on naturally occurring T-Helper cells, and one or
more exterior cell-surface receptors known as FasL, as found on T-Helper
cells infected with the Human Immunodeficiency Virus.

8. A medical device comprised of a capsid shell constructed of repeating
capsid proteins, this capsid shell encapsulated by matrix proteins,
further encapsulated by an exterior lipid bilayer envelope, which affixed
to the outer envelope are at least two different exterior cell-surface
receptors each intended to functionally engage a cell-surface receptor
located on the surface of T-Helper cell infected with Human
Immunodeficiency Virus expressing one or more FasL cell-surface
receptors, with the intention of initiating apoptosis in T-Helper cells
infected with the Human Immunodeficiency Virus in order to terminate
these same T-Helper cells infected with the Human Immunodeficiency Virus
for the purpose of neutralizing the infectious threat of the Human
Immunodeficiency Virus.

9. A medical device comprised of a capsid shell constructed of repeating
capsid proteins, this capsid shell encapsulated by matrix proteins,
further encapsulated by an exterior lipid bilayer envelope, all three
elements similar in construct to the materials and design of the
naturally occurring Human Immunodeficiency Virus with the exterior
envelope having fixed to its exterior cell-surface receptors constructed
in similar physical form and dimensions as generally known and recognized
by the medical scientific community as the Fas cell-surface receptor as
generally found on a naturally occurring human T-Helper cell and the FasL
cell-surface receptor generally found on a T-Helper cell infected with
HIV in a manner and design that the medical device's Fas cell-surface
receptors will attract and functionally engage one or more FasL
cell-surface receptors on a T-Helper cell infected with the Human
Immunodeficiency Virus and one or more FasL cell-surface receptors on the
medical device will attract and functionally engage one or more Fas
cell-surface receptors on the same said HIV infected T-Helper cell with
the intention of initiating apoptosis in T-Helper cells infected with the
Human Immunodeficiency Virus in order to terminate these same T-Helper
cells infected with the Human Immunodeficiency Virus for the purpose of
neutralizing the infectious threat of the Human Immunodeficiency Virus.

10. A medical device comprised of a capsid shell constructed of repeating
capsid proteins, this capsid shell encapsulated by matrix proteins,
further encapsulated by an exterior lipid bilayer envelope, all three
elements similar in construct to the materials and design of the
naturally occurring Human Immunodeficiency Virus with the exterior
envelope having fixed to its exterior cell-surface receptors constructed
in the same physical form and dimensions as generally known and
recognized by the medical scientific community as the Fas cell-surface
receptor as generally found on naturally occurring human T-Helper cells
and the FasL cell-surface receptor generally found on a T-Helper cell
infected with HIV, in a manner and design that a Fas cell-surface
receptor located on the exterior of the medical device will attract and
functionally engage a FasL cell-surface receptor on a T-Helper cell
infected with HIV and a FasL cell-surface receptor on the medical device
will attract and functionally engage a Fas cell-surface receptor on the
same said HIV infected T-Helper cell, where the Fas cell-surface
receptors are present on the outer envelope of the medical device in a
fashion that a Fas cell-surface receptor will be physically engaged by an
infected T-Helper cell before a FasL receptor can be physically engaged
by the same infected T-Helper cell, with the intention of initiating
apoptosis in T-Helper cells infected with the Human Immunodeficiency
Virus in order to terminate these same T-Helper cells infected with the
Human Immunodeficiency Virus for the purpose of neutralizing the
infectious threat of the Human Immunodeficiency Virus.

11. A medical device comprised of a capsid shell constructed of repeating
capsid proteins, this capsid shell encapsulated by matrix proteins which
by this construct determines the size of the device, which is further
encapsulated by an exterior lipid bilayer envelope, all three elements
similar in construct to the materials and design of the naturally
occurring Human Immunodeficiency Virus with the exterior envelope having
fixed to its exterior cell-surface receptors constructed in the same
physical form and dimensions as generally known and recognized by the
medical scientific community as the Fas cell-surface receptor as
generally found on naturally occurring human T-Helper cells and the FasL
cell-surface receptor generally found on a T-Helper cell infected with
HIV, in a manner and design that a Fas cell-surface receptor located on
the exterior of the medical device will attract and functionally engage a
FasL cell-surface receptor on a T-Helper cell infected with HIV and a
FasL cell-surface receptor on the medical device will attract and
functionally engage a Fas cell-surface receptor on the same said HIV
infected T-Helper cell, where the Fas cell-surface receptors are present
on the outer envelope of the medical device in a fashion that a Fas
cell-surface receptor will be physically engaged by an infected T-Helper
cell before a FasL receptor can be physically engaged by the same
infected T-Helper cell, with the intention of initiating apoptosis in
T-Helper cells infected with the Human Immunodeficiency Virus in order to
terminate these same T-Helper cells infected with the Human
Immunodeficiency Virus for the purpose of neutralizing the infectious
threat of the Human Immunodeficiency Virus.

12. A medical device of an overall size that ranges from a thickness of 7
nm to a size in the order of a T-Helper cell approximately 3500 nm in
diameter, comprised of a capsid shell constructed of repeating capsid
proteins, this capsid shell encapsulated by matrix proteins which by this
construct determines the size of the device, which is further
encapsulated by an exterior lipid bilayer envelope, all three elements
similar in construct to the materials and design of the naturally
occurring Human Immunodeficiency Virus with the exterior envelope having
fixed to its exterior cell-surface receptors constructed in the same
physical form and dimensions as generally known and recognized by the
medical scientific community as the Fas cell-surface receptor as
generally found on naturally occurring human T-Helper cells and the FasL
cell-surface receptor generally found on a T-Helper cell infected with
HIV, in a manner and design that a Fas cell-surface receptor located on
the exterior of the medical device will attract and functionally engage a
FasL cell-surface receptor on a T-Helper cell infected with HIV and a
FasL cell-surface receptor on the medical device will attract and
functionally engage a Fas cell-surface receptor on the same said HIV
infected T-Helper cell, where the Fas cell-surface receptors are present
on the outer envelope of the medical device in a fashion that a Fas
cell-surface receptor will be physically engaged by an infected T-Helper
cell before a FasL receptor can be physically engaged by the same
infected T-Helper cell, with the intention of initiating apoptosis in
T-Helper cells infected with the Human Immunodeficiency Virus in order to
terminate these same T-Helper cells infected with the Human
Immunodeficiency Virus for the purpose of neutralizing the infectious
threat of the Human Immunodeficiency Virus.

13. A medical device of an overall size that ranges from a thickness of 7
nm to a size in the order of a T-Helper cell approximately 3500 nm in
diameter, comprised of a capsid shell constructed of repeating capsid
proteins, this capsid shell encapsulated by matrix proteins which by this
construct determines the size of the device, which is further
encapsulated by an exterior lipid bilayer envelope, all three elements
similar in construct to the materials and design of the naturally
occurring Human Immunodeficiency Virus with the exterior envelope having
fixed to its exterior cell-surface receptors constructed in the same
physical form and dimensions as generally known and recognized by the
medical scientific community as the Fas cell-surface receptor as
generally found on naturally occurring human T-Helper cells and the FasL
cell-surface receptor generally found on a T-Helper cell infected with
HIV, in a manner and design that a Fas cell-surface receptor located on
the exterior of the medical device will attract and functionally engage a
FasL cell-surface receptor on a T-Helper cell infected with HIV and a
FasL cell-surface receptor on the medical device will attract and
functionally engage a Fas cell-surface receptor on the same said HIV
infected T-Helper cell, where the Fas cell-surface receptors are present
on the outer envelope of the medical device in a fashion that a Fas
cell-surface receptor will be physically engaged by an infected T-Helper
cell before a FasL receptor can be physically engaged by the same
infected T-Helper cell, with the intention of initiating apoptosis in
T-Helper cells infected with the Human Immunodeficiency Virus in order to
terminate these same T-Helper cells infected with the Human
Immunodeficiency Virus for the purpose of neutralizing the infectious
threat of the Human Immunodeficiency Virus, which the medical device
carries a genetic payload to act as a filler, incapable of stimulating a
disease state in any form of life, required to fill the inside of the
capsid of the medical device in order to support the successful
construction of a particular size of the medical device and to facilitate
the medical device remaining sturdy enough during production and to
insure the medical device will remain intact and functional once
administered as a treatment into an environment where HIV infected
T-Helper cells may exist.

14. A medical device of an overall size that ranges from a thickness of 7
nm to a size to a diameter of one meter, comprised of a capsid shell
constructed of repeating capsid proteins, this capsid shell encapsulated
by matrix proteins which by this construct determines the size of the
device, which is further encapsulated by an exterior lipid bilayer
envelope, all three elements similar in construct to the materials and
design of the naturally occurring Human Immunodeficiency Virus with the
exterior envelope having fixed to its exterior cell-surface receptors
constructed in the same physical form and dimensions as generally known
and recognized by the medical scientific community as the Fas
cell-surface receptor as generally found on naturally occurring human
T-Helper cells and the FasL cell-surface receptor generally found on a
T-Helper cell infected with HIV, in a manner and design that a Fas
cell-surface receptor located on the exterior of the medical device will
attract and functionally engage a FasL cell-surface receptor on a
T-Helper cell infected with HIV and a FasL cell-surface receptor on the
medical device will attract and functionally engage a Fas cell-surface
receptor on the same said HIV infected T-Helper cell, with the intention
of initiating apoptosis in T-Helper cells infected with the Human
Immunodeficiency Virus in order to terminate these same T-Helper cells
infected with the Human Immunodeficiency Virus for the purpose of
neutralizing the infectious threat of the Human Immunodeficiency Virus,
which the medical device carries a genetic payload to act as a filler,
incapable of stimulating a disease state in any form of life, required to
fill the inside of the capsid of the medical device in order to support
the successful construction of a particular size of the medical device
and to facilitate the medical device remaining sturdy enough during
production and to insure the medical device will remain intact and
functional once administered as a treatment into an environment where HIV
infected T-Helper cells may exist.

15. A medical device of an overall size that ranges from a thickness of 7
nm to a size to a diameter of one meter, comprised of a capsid shell
constructed of repeating capsid proteins, this capsid shell encapsulated
by matrix proteins which by this construct determines the size of the
device, which is further encapsulated by an exterior lipid bilayer
envelope, all three elements similar in construct to the materials and
design of the naturally occurring Human Immunodeficiency Virus with the
exterior envelope having fixed to its exterior cell-surface receptors
constructed in the same physical form and dimensions as generally known
and recognized by the medical scientific community as the Fas
cell-surface receptor as generally found on naturally occurring human
T-Helper cells and the FasL cell-surface receptor generally found on a
T-Helper cell infected with HIV, in a manner and design that a Fas
cell-surface receptor located on the exterior of the medical device will
attract and functionally engage a FasL cell-surface receptor on a
T-Helper cell infected with HIV and a FasL cell-surface receptor on the
medical device will attract and functionally engage a Fas cell-surface
receptor on the same said HIV infected T-Helper cell, where the Fas
cell-surface receptors are present on the outer envelope of the medical
device in a fashion that a Fas cell-surface receptor will be physically
engaged by an infected T-Helper cell before a FasL receptor can be
physically engaged by the same infected T-Helper cell, with the intention
of initiating apoptosis in T-Helper cells infected with the Human
Immunodeficiency Virus in order to terminate these same T-Helper cells
infected with the Human Immunodeficiency Virus for the purpose of
neutralizing the infectious threat of the Human Immunodeficiency Virus,
which the medical device carries a genetic payload to act as a filler,
incapable of stimulating a disease state in any life form, required to
fill the inside of the capsid of the medical device in order to support
the successful construction of a particular size of the medical device
and to facilitate the medical device remaining sturdy enough during
production and to insure the medical device will remain intact and
functional once administered as a treatment into an environment where HIV
infected T-Helper cells may exist.

[0006]This invention relates to any medical device intended to physically
interact directly with T-Helper cells infected with the Human
Immunodeficiency Virus (HIV) or infected with other virus, to neutralize
the infectious threat of the virus.

[0007]2. Description of the Background Art

[0008]The Human Immunodeficiency Virus (HIV), which is responsible for
Acquired Immunodeficiency Disease Syndrome (AIDS), threatens the lives of
an estimated 170 millions of people worldwide. There are different
strains of HIV that exist around the world. Most predominantly HIV-1
exists worldwide and HIV-2 is generally found in Western Africa, the
western coastal regions of India and in Europe. Amongst HIV-1 and HIV-2
they can be further subdivided into different strains including an `R5`
strain which uses a CCR5 cell-surface receptor on a T-Helper cell to
identify and access its host and an `X4` strain which uses a CXCR4
cell-surface receptor located on a T-Helper cell to identify and access
its host. The approach to controlling the disease caused by HIV has been
the application of drugs directed at interfering with the replication
process, in an attempt to slow down the rate of replication of the virus.
Millions of people continue to die and the virus continues to pose an
escalating worldwide threat despite current treatment strategies. The
virus is generally communicated between individuals by contact with body
fluids carrying intact HIV.

[0009]Though there are recognized differences between HIV-1 and HIV-2, for
purposes of further discussion the term `HIV` will refer to both HIV-1
and HIV-2, unless otherwise noted. HIV is a retrovirus with its genetic
material in the form of two identical copies of a positive sense single
stranded ribonucleic acid (RNA) molecule, each approximately 9500
nucleotides long. HIV is approximately 50 to 150 nm in diameter, about
one seventieth the size of a white cell carrying the marker Cluster
Designation 4 (CD4) exterior cell-surface receptor.

[0010]A eukaryote refers to a nucleated cell. Eukaryotes comprise nearly
all plant and animal cells. Animal cells generally are comprised of a
cell membrane, cytoplasm, a nucleus and organelles. The cell membrane
consists of a lipid bilayer where two layers of lipid molecules oriented
with their polar ends pointed outside of the membrane and their nonpolar
ends points toward the inside of the membrane. Polarized ends of the
lipid molecules are hydrophobic, therefore the lipid bilayer functions to
control the movement of water, nutrients and hormones in and out of a
cell. A variety of receptors affixed to the exterior of the lipid bilayer
membrane assist in a cell communicating with its environment. The
cytoplasm inside a cell, which forms the interior fluid matrix of the
cell, is comprised of amino acids and nutrients. The nucleus is
surrounded by a double membrane (often referred to as a nuclear membrane)
and contains the majority of a cell's genetic material. Organelles are
structures generally found in the cytoplasm that perform specialized
functions of cells. Organelles found inside a cell may include the
mitochondria, endoplasmic reticulum, Golgi complex, lysosomes, vacuoles.

[0011]Genetic material in a eukaryote is generally in the form of
deoxyribonucleic acid (DNA) with the majority located in the nucleus of
the cell, but DNA may also be found in the mitochondria of cells. By the
process of transcription, a section of the DNA is read by a polymerase
and a molecule of ribonucleic acid (RNA) is generated. DNA is comprised
of sections of combinations of four nucleotides: adenine, cytosine,
guanine, and thymine. When two strands of nucleotides are arranged
together, such as in the double helix configuration of chromosomal DNA,
adenine on one strand is always matched to thymine in the opposing
strand, and cytosine on one strand is always matched to guanine in the
opposing strand. RNAs generated by polymerases reading nuclear DNA are
usually single stranded chains of nucleotides, constructed of similar
adenine, cytosine and guanine nucleotides as DNA, but instead of
`thymine`, RNAs are constructed with the nucleotide `uracil`. RNAs are
generally divided into three categories including messenger RNA (mRNA),
ribosomal RNA (rRNA) and transfer RNA (tRNA). Messenger RNAs are
considered positive sense and interact with ribosomes to generate protein
molecules. Ribosomes read the code physically built into the messenger
RNAs, and with the aid of rRNAs and tRNAs, generate protein molecules by
bonding together amino acids in linear configurations as directed by the
code on a messenger RNA.

[0012]Blood cells are generally referred to as white blood cells and red
blood cells. Thrombocytes, otherwise known as platelets, are flat
disk-shaped cell fragments that circulate the blood to assist with
clotting when required. White blood cells, also referred to as
leukocytes, play an active role in the body's immune system. White blood
cells are further divided into T-Cells and B-Cells. T-Helper cells, also
known as CD4 T-lymphocytes or CD4 T-Cells, are a subset of white blood
cells. T-Helper cells act to coordinate the body's immune response
against infectious agents. A significant decline in the number of
circulating T-Helper cells represents a state where the body is
vulnerable to opportunistic infections such a pneumonia, fungal
infections or other common ailments.

[0013]Viruses are obligate intracellular parasites designed to infect
cells often with great specificity to a particular cell type it uses as a
host. Virion is a term that refers to a complete structure of a virus as
it exists outside of a host cell. Viruses do not carry out any
biologically active processes on their own when outside a host cell. A
virus requires a host in order to reproduce itself. Viruses circulate the
environment without the need for nutrition or energy production through
respiration. Viruses are in essence a vehicle that carries the genetic
programming instructions necessary to cause an appropriate host cell to
generate identical copies of the same virus. Some viruses, such as HIV,
do introduce to their host cells programming instructions that result in
toxic effects to the body as a whole.

[0014]HIV is considered to be approximately spherical in shape and
comprised of an outer lipid bilayer envelope, a matrix protein, a capsid,
two strands of RNA, nucleocapsid protein and proteins to assist in the
replication process. The virus's core or capsid is icosahedral in shape
and acts as a protective shell to carry the genetic payload. The capsid
is comprised of numerous copies of the capsid protein (p24), the number
and arrangement of the capsid proteins determines the overall dimensions
of the capsid shell; HIV uses approximately 2,000 capsid proteins (p24)
to construct its capsid. The capsid carries the two single strands of RNA
each containing a copy of the virus's nine genes, the nucleocapsid
protein, reverse transcriptase, protease and integrase. The nucleocapsid
protein causes the RNA to coil up so that it can fit inside the capsid.
The protein matrix consisting of protein 17 (p17) covers the capsid. The
HIV envelope is derived from the plasma membrane of the host cell as the
virus buds or pushes through the host cell's plasma membrane as it exits
and migrates from the host cell. Anchored in and projecting out from the
HIV's lipid bilayer outer membrane, otherwise referred to as an envelope,
are exterior probes well known to the medical and scientific community as
glycoprotein 120 (gp 120) and glycoprotein 41 (gp 41). The term
glycoprotein refers to a protein with a carbohydrate attached. The gp 41
probe is anchored to the outer envelope and is in close proximity to the
gp 120 probe. The probes can be found arranged together into protein
complexes, which may contain up to three gp 120 probes and three gp 41
probes. Protein complexes have been described as `spikes`. It has been
reported that an HIV outer envelope may project from ten to seventy-two
said spikes.

[0015]A HIV virion transits the environment at large with its surface
probes seeking to engage a human T-Helper cell. Human T-Helper cells
express a number of cell-surface receptors on their outer plasma membrane
including Cluster Designation 4 (CD4), Chemotactic Chemokine Receptor 5
(CCR5) and CX Chemokine Receptor 4 (CXCR4). HIV utilizes the human
T-Helper cell, also known as a CD4 T-lymphocyte or CD4 T-Cell, as its
host for the purpose of replicating copies of itself. To initiate its
reproductive-cycle, the gp 120 probe on a HIV virion makes initial
contact with a T-Helper cell's CD4 cell-surface receptor. Following the
engagement of the gp 120 probe with the CD4 cell-surface receptor, the gp
120 probe alters its configuration to allow the HIV gp 41 probe to engage
a second receptor on the surface of the T-Helper cell, either a CCR5
cell-surface receptor or a CXCR4 cell-surface receptor. Once the HIV
virion's gp 120 probe has successfully engaged a T-Helper cell's CD4
cell-surface receptor and the HIV's gp 41 probe has successfully engaged
the T-Helper cell's CCR5 or CXCR4 cell-surface receptor, then the HIV
virion is able to transfer its capsid containing the two strands of
ribonucleic acid (RNA) and the support proteins including reverse
transcriptase, protease, and integrase into the T-Helper cell. Once the
capsid has gained access to the interior of the T-Helper cell, utilizing
the transferred HIV enzyme `reverse transcriptase`, the RNA molecules
undergo reverse transcription to deoxyribonucleic acid (DNA). Protease
helps modify HIV's genome. Aided by the integrase, the virus's RNA that
has been transcribed into DNA migrates to the T-Helper cell's nucleus and
is known to become inserted into the T-Helper cell's native DNA. The HIV
genetic material then redirects the resources of the T-Helper cell to
facilitate the manufacture of copies of HIV.

[0016]Most predominantly HIV-1 exists worldwide and HIV-2 is generally
found in Western Africa, the western coastal regions of India and Europe.
Amongst HIV-1 and HIV-2 that use CD4 as the initial cell-surface receptor
to gain entry into a T-Helper cell, they can be further divided by an
`R5` strain which uses a CCR5 cell-surface receptor on a T-Helper cell to
identify its host; an `X4` strain which uses a CXCR4 cell-surface
receptor located on a T-Helper cell to identify its host. It is also
believed at least one strain of HIV-2 may infect a T-Helper cell without
engaging a CD4 cell-surface receptor, but uses either a CCR5 or a CXCR4
cell-surface receptor on a T-Helper cell host. There has also been
identified at least one strain of HIV-2 believed not utilize the CD4,
CCR5 or the CXCR4 cell-surface receptors to engage a T-Helper cell host,
the mode of entry utilized by this form or HIV virion is unknown at this
time.

[0017]The Fas cell-surface receptor (also referred to as CD95 cell-surface
receptor) appears naturally on the surface of T-Helper cells. The Fas
cell-surface receptor, when triggered, will transmit into the cell a
biologic signal to activate the process of apoptosis. Apoptosis is a
natural process utilized to terminate a cell, resulting in cell death.

[0018]Naturally occurring T-Helper cells, not infected with HIV, help
orchestrate the human body's immune response against infectious agents
that threaten the health and integrity of the body. The HIV virus, by
taking control and altering the function of the T-Helper cells in the
body, creates a state of ill health. By redirecting the T-Helper cell's
function to produce copies of the HIV virus rather than coordinate
appropriate immune responses against potentially infectious agents leaves
the body as a whole vulnerable to attack by other infectious agents that
can do harm to the tissues of the body. In addition, the HIV genome
carries a `nef` gene. Once the HIV's DNA is inserted into the host cell's
native DNA, the nef gene provides instructions for a Fas ligand (FasL)
cell-surface marker to be manufactured and expressed on the surface of
the infected T-Helper cell. Noninfected T-Helper cells (meaning not
infected with HIV) express a Fas cell-surface marker. When a HIV infected
T-Helper cell expressing the Fas ligand (FasL) cell-surface marker
encounters a Fas cell-surface marker on a noninfected T-Helper cell, a
lethal biologic signal is transmitted to the noninfected T-Helper cell.
That is when the FasL cell-surface marker engages a Fas cell-surface
marker, the process of apoptosis is triggered in the noninfected T-Helper
cell. By triggering apoptosis in noninfected T-Helper cells, HIV infected
T-Helper cells are capable of killing the noninfected T-Helper cells they
encounter. The clinical ramifications of Acquired Immunodeficiency
Syndrome (AIDS) occur when the number of noninfected T-Helper cells
declines to the point the immune system is unable to defend the body as a
whole from dangerous infectious agents that would attempt to invade the
body's tissues.

[0019]T-Helper cells infected with HIV pose possibly the greatest threat
to the integrity of a body's immune system by terminating noninfected
T-Helper cells, which a critical number of noninfected T-Helper cells is
needed to defend the body from infectious agents. Since the clinical
characteristics of AIDS appears to coincide more with the decline of
non-infected T-Helper cells below a critical number and not necessarily
with the number of HIV infected T-Helper cells, controlling the
population of HIV infected T-Helper cells or ridding the environment of
HIV infected T-Helper cells would be a successful approach to managing
AIDS.

BRIEF SUMMARY OF THE INVENTION

[0020]A Scientifically Modulated And Reprogrammed Treatment (SMART)
Fas/FasL Virus is comprised of an inner capsid similar to the naturally
occurring HIV icosahedral capsid. The SMART-Fas/FasL Virus capsid is
encapsulated with a protein matrix similar to the protein matrix that
encapsulates the HIV's capsid. A lipid bilayer envelope then encapsulates
the matrix protein coat and capsid similar to the lipid bilayer that
encapsulates the matrix protein of HIV. Two cell-surface receptors Fas
and Fas ligand (FasL) would be fixed to the surface of the SMART-Fas/FasL
Virus. The capsid of the medically therapeutic version of the
SMART-Fas/FasL Virus would carry either no genetic payload or would carry
RNA molecules that would not be capable of replicating the virus-like
structure in the natural environment or causing any disease in any form
of life. The amount of genetic payload or filler would relate to the
intended size and stability of the SMART-Fas/FasL Virus. SMART-Fas/FasL
Viruses are intended to engage T-Helper cells infected with HIV that are
expressing the FasL cell-surface receptor. Once an infected T-Helper
cell's FasL cell-surface receptor engages a Fas cell-surface receptor on
the SMART-Fas/FasL Virus, the SMART-Fas/FasL Virus's FasL cell-surface
receptor engages a Fas cell-surface receptor on the infected T-Helper
cell. Once the infected T-Helper cell's Fas cell-surface receptor has
been engaged, a biologic signal is triggered inside the infected T-Helper
cell that initiates the process of apoptosis. The process of apoptosis
terminates the infected T-Helper cell.

DETAILED DESCRIPTION

[0021]Scientifically Modulated And Reprogrammed Treatment (SMART) Fas/FasL
Virus technology is intended to neutralize T-Helper cells infected with
the Human Immunodeficiency Virus. A Scientifically Modulated And
Reprogrammed Treatment (SMART) Fas/FasL Virus is comprised of an inner
capsid similar to the naturally occurring HIV icosahedral capsid. The
SMART-Fas/FasL Virus capsid would be encapsulated with a protein matrix
similar to the protein matrix that encapsulates the HIV's capsid. A lipid
bilayer envelope then encapsulates the matrix protein coat and capsid
similar to the lipid bilayer that encapsulates HIV's matrix protein and
inner capsid. Two cell-surface receptors Fas (also known as CD98) and Fas
ligand (FasL) would be fixed to the surface of the SMART-Fas/FasL Virus.
The capsid of the therapeutic version of the SMART-Fas/FasL Virus would
carry either no genetic payload or would carry RNA molecules that would
not be capable of replicating the virus-like structure in the natural
environment or causing any disease in any form of life. The amount of
genetic payload or filler would relate to the intended stability of the
SMART-Fas/FasL Virus. Within the SMART-Fas/FasL Virus's outer envelope
are matrix protein and a capsid to act as the interior conformational
structure to provide the appropriate size and shape to the outer envelope
as needed for the intended use. The size of the SMART-Fas/FasL Virus
ranges from 7 nanometer (nm) in thickness (the diameter of HIV is
approximately 50 to 150 nm) to a diameter in the order of the size of a
naturally occurring noninfected T-Helper cell, and up to a diameter of
one meter. T-Helper cells are mobile structures and constantly alter
their shape and size, but are approximately 3500 nm in diameter. The
range in size of the SMART-Fas/FasL Virus is dependent upon the type of
application for which the SMART-Fas/FasL Virus is intended to be
utilized.

[0022]A SMART-Fas/FasL Virus is intended to engage a T-Helper cell
infected with HIV that is expressing the FasL cell-surface receptor. Once
an infected T-Helper cell's FasL cell-surface receptor engages a Fas
cell-surface receptor on the said SMART-Fas/FasL Virus, the
SMART-Fas/FasL Virus's FasL cell-surface receptor engages a Fas
cell-surface receptor on the infected T-Helper cell. Once the infected
T-Helper cell's Fas cell-surface receptor has been engaged, a biologic
signal is triggered inside the infected T-Helper cell that initiates the
process of apoptosis. Apoptosis is a naturally occurring biologic process
present in cells that when initiated results in cell death. Activation of
apoptosis terminates the infected T-Helper cell. In the event HIV is
unable to successfully create additional copies of itself and unable to
further threaten noninfected T-Helper cells, the threat of Acquired
Immunodeficiency Disease Syndrome is successfully neutralized.

[0023]SMART-Fas/FasL Virus technology can be used as a cleaning device to
neutralize and rid a surface or a fluid environment of HIV infected
T-Helper cells. SMART-Fas/FasL Virus is intended to engage HIV infected
T-Helper cells where ever it may exist.

[0024]HIV utilizes T-Helper cells as a natural factory for generating
copies of HIV. HIV utilizes a fusion technique where the virion envelope
fuses with the cellular membrane of the host cell and directly releases
the capsid containing the RNA genome and replicating enzymes into the
cytoplasm of the host cell. HIV utilizes enzymes created by its own
genome and enzymes native to the T-Helper cell to generate the proteins
it requires to construct copies of HIV. Once the appropriate copies of
the RNA, nucleocapsid protein, integrase, protease, reverse transcriptase
enzyme, capsid proteins, matrix protein and external probes have been
manufactured and collected together, the capsid carrying the RNA genetic
payload is enveloped by the matrix protein and pushes through the host
cell's plasma membrane in a process called budding. The HIV copy becomes
encapsulated in an envelope comprised of a lipid bilayer as it separates
from the host cell and becomes an independent entity termed a virion.
Probes stick out through the lipid bilayer envelope of the virion to seek
the receptors located on an appropriate host cell.

[0025]To produce copies of the SMART-Fas/FasL Virus a T-Helper cell can be
utilized, bacteria with a lipid bilayer membrane could be utilized,
hybrid cells (combination of animal cell, plant cell or bacteria) could
be utilized or other appropriate host cell could be utilized. The
technology to manufacture viruses carrying a therapeutic DNA gene has
already been worked out and implemented. The process to generate a
medically therapeutic virus to target a particular type of cell is a
matter of placing inside a host cell the appropriate genetic instructions
and enzymes to facilitate the host cell to manufacture the intended
`medically therapeutic` virus.

[0026]In the case of the SMART-Fas/FasL Virus, the construction of the
medically therapeutic copies of the SMART-FasL Virus include the
appropriate instructions and biologic machinery necessary to generate the
capsid proteins, matrix proteins, external cell-surface receptors Fas and
FasL, any filling material to be placed inside the capsid and any cell
instruction proteins necessary to stimulate and manage the budding
process. The Fas cell-surface receptor is a naturally occurring
cell-surface receptor on T-Helper cells. The genetic instruction code for
manufacturing the FasL receptor and fixing it on the lipid bilayer as a
receptor is available and carried in the HIV genome. The size of the
capsid is dependent upon the quantity of capsid proteins used to
construct the capsid. For descriptive purposes the use of the term
`capsid` is interchangeable with the term `capsid shell`. Different
naturally occurring viruses are constructed with a different size capsid
depending upon the number and arrangement of capsid proteins utilized to
construct a virus's capsid. The diameter of the SMART-Fas/FasL Virus is
in part dependent upon the number and arrangement of capsid proteins used
to construct the capsid. A genetic payload to act as a filler, incapable
of stimulating a disease state in any form of life, may be required to
fill the inside the capsid of some of the larger diameter SMART-Fas/FasL
Viruses in order to support the successful construction of a particular
size of SMART-Fas/FasL Virus and to facilitate the SMART-Fas/FasL Virus
remaining sturdy enough and thus intact once released into the
environment to enable it to successfully carry out its intended function.

[0027]The size of the SMART-Fas/FasL Virus is between 7 nm in thickness
(the diameter of HIV is approximately 50 to 150 nm) to a diameter in the
order of the size of a naturally occurring noninfected T-Helper cell, to
a diameter of one meter. The size of the SMART-Fas/FasL Virus is variable
due to the range of applications for which the SMART-Fas/FasL Virus is
intended to be utilized. The SMART-Fas/FasL Virus may take on the shape
of simply a relatively flat sheet of varying sizes which may be folded
into various configurations, to spherical structures of varying sizes to
irregularly shaped convoluted structures of varying sizes. The unique
principle of intent is to engage infected T-Helper cells with Fas
cell-surface receptors and FasL cell-surface receptors in whatever manner
might terminate T-Helper cells infected with the Human Immunodeficiency
Virus.